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Poster

P-DCM-022

Analytical and Clinical performance evaluation of the FluoroType® MTBDR VER 2.0 with Dual Target Detection of Mycobacterium tuberculosis Complex from Native Sputum and Culture

Presented in

Poster Session 2

Poster topics

Diagnostic and Clinical Microbiology

Authors

Vera Allerheiligen (Nehren / DE), Martin Eckart (Nehren / DE), Lisa Wolf (Nehren / DE), Stefan Fischer (Nehren / DE)

Abstract

Introduction: The WHO-endorsed FluoroType® MTBDR VER 2.0 based on the LiquidArray® technology is an important tool in diagnosis of TB and its resistance-mediating mutations against first-line antibiotics rifampicin and isoniazid. The multi-copy target IS6110 was integrated into the FluoroType MTBDR VER 2.0 as a second target for M. tuberculosis complex (MTBC) detection. In this study we determined the analytical and clinical performance of the modified assay.

Methods: The modified FluoroType MTBDR VER 2.0 in combination the Liquefaction Set VER 1.0 allows easy and simultaneous detection of MTBC and its resistance to rifampicin and isoniazid directly from native sputum specimens. In total 8 workflows for manual and automated DNA extraction from native sputum and culture samples have been evaluated using the GenoXtract® and GenoXtract® fleXT instruments in combination with the FluoroCycler® XT. The system enables a rapid and automated processing with minimal hands-on time and fully automated evaluation. Reported mutations were adapted to the recently published WHO catalogue of resistance mediating-mutations.

Results: Integration of IS6110 leads to a high sensitivity of MTBC detection. Within the analytical performance study an excellent performance of the assay could be demonstrated. The FluoroType MTBDR VER 2.0 allows reliable detection and identification of most relevant mutations in rpoB, katG and the inhA promoter region responsible for resistance to rifampicin and isoniazid. It also identifies silent mutations within rpoB. The Liquefaction Set VER 1.0 inactivates and liquifies native sputum very effectively in one step. The excellent performance for MTBC and resistance detection was also demonstrated in a clinical study with ca. 600 patient samples.

Summary: The modified FluoroType MTBDR VER 2.0 allows a highly sensitive detection of MTBC and differentiates important mutations responsible for resistance based on the WHO catalogue of mutations. It enables sensitive detection of MTBC and identification of mutations directly from native sputum specimens. Additionally, NALC-NaOH decontaminated sputum samples and culture samples can be analyzed.